US20040236309A1 - Mesh ventricular catheter with antithrombogenic coating - Google Patents
Mesh ventricular catheter with antithrombogenic coating Download PDFInfo
- Publication number
- US20040236309A1 US20040236309A1 US10/440,843 US44084303A US2004236309A1 US 20040236309 A1 US20040236309 A1 US 20040236309A1 US 44084303 A US44084303 A US 44084303A US 2004236309 A1 US2004236309 A1 US 2004236309A1
- Authority
- US
- United States
- Prior art keywords
- catheter
- mesh
- tube
- disposed
- mesh fabric
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/0005—Use of materials characterised by their function or physical properties
- A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
- A61L33/0029—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate using an intermediate layer of polymer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
Definitions
- the field of the invention relates to medical devices, and more particularly, to catheters.
- This invention relates to surgically implanted drainage catheters. Such devices are often used as part of shunt systems to divert cerebrospinal fluid from the brain to another part of the body.
- Shunt systems have widespread use in the treatment of hydrocephalus. Cerebrospinal fluid is continuously produced in the brain and normally circulated through the central nervous system before being absorbed into the bloodstream. In the case of hydrocephalus, fluid that should drain away, instead, accumulates within the cerebral ventricles thereby causing elevated intracranial pressure. The pressure is transmitted to sensitive brain structures resulting in neurological debilitation or even death.
- the treatment of hydrocephalus typically involves the insertion of a ventricular catheter through a burr hole in the skull.
- the ventricular catheter is connected to a pressure valve and distal tubing that is tunneled subcutaneously to shunt cerebrospinal fluid to another part of the body, most commonly the peritoneal cavity of the abdomen.
- a novel catheter for use within the cerebral ventricles of the human body.
- the catheter includes an impermeable tubular substrate, a mesh of a relatively constant sieve size disposed over the substrate and an antithrombogenic coating disposed on all surfaces of the mesh.
- FIG. 1 illustrates the use of a shunt system implanted in a patient 12 for the treatment of hydrocephalus
- FIG. 2 depicts a detailed view of a ventricular catheter that may be used with the system of FIG. 1.
- FIG. 1 depicts a shunt system 10 that may be used in the treatment of hydrocephalus.
- the system 10 may include a catheter 14 implanted into a ventricle within the cranial cavity of a patient 12 .
- a valve mechanism 13 may be connected to an open end of the ventricular catheter 14 to regulate drainage pressure.
- a separate tube 16 may be connected to the other end of the valve mechanism 13 to shunt fluid to another part of the body of the patient (e.g. the peritoneal cavity).
- FIG. 2 shows a side view of the ventricular catheter 14 .
- the ventricular catheter 14 may include a semipermeable mesh filter assembly 24 supported by a substrate.
- the substrate may include a body 18 (e.g., made of silastic elastomer tubing) with a number of slots 26 .
- the body 18 may also include a distal tube connection end 20 and a proximal infusion end 22 .
- the mesh filter assembly 24 that is disposed on the infusion end 22 allows free passage of fluids into a lumen that extends the length of the body 18 , through the valve mechanism 13 and out through the tube 16 . Concurrently, the mesh filter assembly 24 is a barrier to the ingrowth of tissue. The unique combination of free diffusion to fluids and impermeability to tissue proliferation allows the ventricular catheter to function more effectively than shunt devices described in the prior art.
- the mesh filter assembly 24 may include a mesh filter element 30 .
- the mesh filter element 30 may be constructed in such a way as to provide an array of openings of a relatively constant sieve size.
- the openings may be selected of a macrocellular size that is capable of allowing single cells or small groups of cells to pass through, but which are too small to allow for tissue ingrowth.
- a square mesh sieve of a macrocellular size is in the range from 50 to 150 microns on each side, with a preferred size of approximately 100 microns on each side.
- a factor essential to the long-term functioning of such a ventricular catheter is the use of an antithrombogenic substance 28 to provide a biologically inert coating on the surface of the mesh filter element 30 .
- an antithrombogenic substance 28 to provide a biologically inert coating on the surface of the mesh filter element 30 .
- What had not been recognized in the prior art are the benefits of combining a macrocellular opening size with a passivating substance that reduces cellular and proteinaceous adhesion.
- the mesh filter assembly 24 may be created under any of a number of processes.
- a mesh filter element 30 comprised of a metal (e.g., stainless steel) or polymer (e.g., polyethylene) is provided with a relatively constant sieve size (e.g., approximately 100 microns on a side).
- the mesh surface may then be coated with an antithrombogenic coating 28 (e.g. polyvinylpyrrolidone and/or heparin).
- the catheter 14 may be prepared by creating two or more slots 26 disposed around the infusion end 22 of the substrate 18 (e.g., silastic elastomer tubing) with the longitudinal axis of each slot 26 aligned parallel with the length of the substrate 18 .
- the end of the substrate 18 is tapered beyond the mesh filter element 30 to a blunt tip that is minimally destructive to brain tissue during catheter implantation.
- a biocompatible adhesive e.g., silicone-based
- silicone-based may be disposed around an outside surface of the infusion end 22 of the substrate 18 , around the longitudinally arranged slots 26 .
- a single layer of the mesh filter element 30 may be trimmed to size and adhered circumferentially around the infusion end 22 to completely overlie the slots 26 .
- the presence of the macrocellular sieve allows fluids, protein, and small cellular aggregates to easily pass through the mesh filter assembly 24 .
- the importance of selecting a macrocellular mesh sieve to allow clearance of cellular debris had not been appreciated in the prior art.
- the mesh filter assembly 24 prevents brain tissue from proliferating into and obstructing the filter assembly, thereby reducing the possibility of catheter obstruction.
- the passivating antithrombogenic coating 28 retards any adherence of proteinaceous or cellular components to the mesh filter assembly 24 thereby assuring the catheter 14 a longer useful life than that experienced by prior art catheters.
Abstract
A catheter is provided for use within the cerebral ventricle of the human body. The catheter includes a tubing substrate, a semipermeable mesh of a relatively constant sieve size disposed over the substrate and an antithrombogenic coating disposed on all surfaces of the semipermeable mesh.
Description
- The field of the invention relates to medical devices, and more particularly, to catheters.
- This invention relates to surgically implanted drainage catheters. Such devices are often used as part of shunt systems to divert cerebrospinal fluid from the brain to another part of the body.
- Shunt systems have widespread use in the treatment of hydrocephalus. Cerebrospinal fluid is continuously produced in the brain and normally circulated through the central nervous system before being absorbed into the bloodstream. In the case of hydrocephalus, fluid that should drain away, instead, accumulates within the cerebral ventricles thereby causing elevated intracranial pressure. The pressure is transmitted to sensitive brain structures resulting in neurological debilitation or even death.
- Alteration of normal cerebrospinal fluid pathways can result from a congenital defect, intraventricular hemorrhage, brain injury, infection, or brain tumor. Hydrocephalus most commonly occurs in children, although adults can be similarly afflicted by the aforementioned etiologic mechanisms.
- The treatment of hydrocephalus typically involves the insertion of a ventricular catheter through a burr hole in the skull. The ventricular catheter is connected to a pressure valve and distal tubing that is tunneled subcutaneously to shunt cerebrospinal fluid to another part of the body, most commonly the peritoneal cavity of the abdomen.
- While shunt systems described above are life saving, they are also subject to malfunction, most commonly due to obstruction of the ventricular catheter. In such cases, negative pressure within the catheter lumen encourages surrounding tissue to grow into the openings of the catheter thereby blocking the proper functioning of the catheter.
- Another common cause of ventricular catheter obstruction is encrustation of catheter openings by proteinaceous or cellular matter. Such is a challenge for all implanted devices since most foreign materials instigate the coagulation cascade and invite protein adhesion.
- Some children undergo tens to hundreds of operations for shunt revision. Because of the importance of implantable catheters, a need exists for a shunt system whose operation is not impeded by ingrowing tissue and whose components are biologically passivating.
- A novel catheter is provided for use within the cerebral ventricles of the human body. The catheter includes an impermeable tubular substrate, a mesh of a relatively constant sieve size disposed over the substrate and an antithrombogenic coating disposed on all surfaces of the mesh.
- FIG. 1 illustrates the use of a shunt system implanted in a
patient 12 for the treatment of hydrocephalus; and - FIG. 2 depicts a detailed view of a ventricular catheter that may be used with the system of FIG. 1.
- FIG. 1 depicts a
shunt system 10 that may be used in the treatment of hydrocephalus. As shown, thesystem 10 may include acatheter 14 implanted into a ventricle within the cranial cavity of apatient 12. Avalve mechanism 13 may be connected to an open end of theventricular catheter 14 to regulate drainage pressure. Aseparate tube 16 may be connected to the other end of thevalve mechanism 13 to shunt fluid to another part of the body of the patient (e.g. the peritoneal cavity). - FIG. 2 shows a side view of the
ventricular catheter 14. As shown, theventricular catheter 14 may include a semipermeablemesh filter assembly 24 supported by a substrate. The substrate may include a body 18 (e.g., made of silastic elastomer tubing) with a number ofslots 26. Thebody 18 may also include a distaltube connection end 20 and aproximal infusion end 22. - The
mesh filter assembly 24 that is disposed on theinfusion end 22 allows free passage of fluids into a lumen that extends the length of thebody 18, through thevalve mechanism 13 and out through thetube 16. Concurrently, themesh filter assembly 24 is a barrier to the ingrowth of tissue. The unique combination of free diffusion to fluids and impermeability to tissue proliferation allows the ventricular catheter to function more effectively than shunt devices described in the prior art. - The
mesh filter assembly 24 may include amesh filter element 30. Themesh filter element 30 may be constructed in such a way as to provide an array of openings of a relatively constant sieve size. In general, the openings may be selected of a macrocellular size that is capable of allowing single cells or small groups of cells to pass through, but which are too small to allow for tissue ingrowth. As used herein, a square mesh sieve of a macrocellular size is in the range from 50 to 150 microns on each side, with a preferred size of approximately 100 microns on each side. - A factor essential to the long-term functioning of such a ventricular catheter is the use of an
antithrombogenic substance 28 to provide a biologically inert coating on the surface of themesh filter element 30. What had not been recognized in the prior art are the benefits of combining a macrocellular opening size with a passivating substance that reduces cellular and proteinaceous adhesion. - It has been known in the art that most foreign materials trigger the coagulation cascade in the presence of blood. This phenomenon is exaggerated for semipermeable barriers with small pores since the ratio of reactive surface area to drainage area is high. As a result, semipermeable barriers by themselves have not been successfully employed in implanted catheters. Current catheters are generally constructed with large apertures, with diameters of 500 microns or greater, directly bored into the tubular substrate.
- The
mesh filter assembly 24 may be created under any of a number of processes. For example, amesh filter element 30 comprised of a metal (e.g., stainless steel) or polymer (e.g., polyethylene) is provided with a relatively constant sieve size (e.g., approximately 100 microns on a side). The mesh surface may then be coated with an antithrombogenic coating 28 (e.g. polyvinylpyrrolidone and/or heparin). - The
catheter 14 may be prepared by creating two ormore slots 26 disposed around theinfusion end 22 of the substrate 18 (e.g., silastic elastomer tubing) with the longitudinal axis of eachslot 26 aligned parallel with the length of thesubstrate 18. The end of thesubstrate 18 is tapered beyond themesh filter element 30 to a blunt tip that is minimally destructive to brain tissue during catheter implantation. - A biocompatible adhesive (e.g., silicone-based) may be disposed around an outside surface of the
infusion end 22 of thesubstrate 18, around the longitudinally arrangedslots 26. A single layer of themesh filter element 30 may be trimmed to size and adhered circumferentially around theinfusion end 22 to completely overlie theslots 26. - The presence of the macrocellular sieve allows fluids, protein, and small cellular aggregates to easily pass through the
mesh filter assembly 24. The importance of selecting a macrocellular mesh sieve to allow clearance of cellular debris had not been appreciated in the prior art. In addition, themesh filter assembly 24 prevents brain tissue from proliferating into and obstructing the filter assembly, thereby reducing the possibility of catheter obstruction. The passivatingantithrombogenic coating 28 retards any adherence of proteinaceous or cellular components to themesh filter assembly 24 thereby assuring the catheter 14 a longer useful life than that experienced by prior art catheters. - A specific embodiment of a method and apparatus for providing a catheter has been described for the purpose of illustrating the manner in which the invention is made and used. It should be understood that the implementation of other variations and modifications of the invention and its various aspects will be apparent to one skilled in the art, and that the invention is not limited by the specific embodiments described. Therefore, it is contemplated to cover the present invention and any and all modifications, variations, or equivalents that fall within the true spirit and scope of the basic underlying principles disclosed and claimed herein.
Claims (24)
1. A ventricular catheter for use within a ventricle of a human body, such catheter comprising:
a substrate;
a filter assembly of a relatively constant sieve size disposed over the substrate; and
an antithrombogenic coating disposed on all surfaces of the semipermeable mesh.
2. The catheter as in claim 1 wherein the substrate further comprises a tube.
3. The catheter as in claim 2 wherein the tube further comprises a plurality of aperatures disposed in a wall of the tube.
4. The catheter as in claim 3 wherein the plurality of apertures disposed in a wall of the tube further comprises a plurality of longitudinal slots disposed in the tube.
5. The catheter as in claim 1 wherein the filter assembly further comprises a mesh fabric of a relatively constant sieve size.
6. The catheter as in claim 5 wherein the mesh fabric further comprises stainless steel.
7. The catheter as in claim 5 wherein the mesh fabric further comprises polyethylene.
8. The catheter as in claim 5 wherein the mesh fabric further comprises a sieve size selected from a range of sieve sizes that lie between 50 and 150 microns on each side.
9. The catheter as in claim 5 wherein the filter assembly further comprises a single layer of the mesh fabric disposed around the tube.
10. The catheter as in claim 5 wherein the mesh further comprises a nominal pore size of 100 microns.
11. The catheter as in claim 1 wherein the antithrombogenic coating further comprises polyvinylpyrrolidone.
12. The catheter as in claim 1 wherein the antithrombogenic coating further comprises heparin.
13. A catheter for use within a ventricle of a human body, such catheter comprising:
a tube with a plurality of longitudinal slots disposed in the tube;
a mesh fabric disposed around the tube covering the plurality of longitudinal slots; and
a coating of an antithrombogenic substance disposed on a surface of the mesh fabric.
14. The catheter as in claim 13 wherein the mesh further comprises stainless steel.
15. The catheter as in claim 13 wherein the mesh further comprises polyethylene.
16. The catheter as in claim 13 wherein the mesh further comprises a sieve size of from 50 to 150 microns.
17. The catheter as in claim 13 wherein the mesh further comprises a nominal pore size of 100 microns.
18. The catheter as in claim 13 wherein the antithrombogenic substance further comprises polyvinylpyrrolidone.
19. The catheter as in claim 13 wherein the antithrombogenic substance further comprises heparin.
20. The catheter as in claim 13 wherein the mesh fabric further comprises a single layer of the mesh fabric disposed around the tube.
21. A catheter for use within a ventricle of a human body, such catheter comprising:
a tube with a plurality of longitudinal slots disposed in the tube; and
a mesh fabric possessing macrocellular sieves disposed around the tube covering the plurality of longitudinal slots.
22. The catheter as in claim 21 wherein the mesh fabric further comprises a coating of an antithrombogenic substance disposed on a surface of the mesh fabric.
23. The catheter as in claim 21 wherein the mesh further comprises stainless steel.
24. The catheter as in claim 21 wherein the mesh fabric comprises polyethylene.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/440,843 US20040236309A1 (en) | 2003-05-19 | 2003-05-19 | Mesh ventricular catheter with antithrombogenic coating |
Applications Claiming Priority (1)
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US10/440,843 US20040236309A1 (en) | 2003-05-19 | 2003-05-19 | Mesh ventricular catheter with antithrombogenic coating |
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US20040236309A1 true US20040236309A1 (en) | 2004-11-25 |
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US10/440,843 Abandoned US20040236309A1 (en) | 2003-05-19 | 2003-05-19 | Mesh ventricular catheter with antithrombogenic coating |
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Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080051691A1 (en) * | 2006-08-28 | 2008-02-28 | Wyeth | Implantable shunt or catheter enabling gradual delivery of therapeutic agents |
WO2008027322A1 (en) * | 2006-08-28 | 2008-03-06 | Wyeth | Implantable shunt or catheter enabling gradual delivery of therapeutic agents |
US20100191168A1 (en) * | 2009-01-29 | 2010-07-29 | Trustees Of Tufts College | Endovascular cerebrospinal fluid shunt |
US8088091B2 (en) | 2009-03-09 | 2012-01-03 | New Jersey Institute Of Technology | No clog shunt using a compact fluid drag path |
EP2877226A1 (en) * | 2012-07-26 | 2015-06-03 | Twin Star Medical, Inc. | Macroporous catheter |
US9387311B1 (en) | 2014-10-31 | 2016-07-12 | Cerevasc, Llc | Methods and systems for treating hydrocephalus |
US9737696B2 (en) | 2014-01-15 | 2017-08-22 | Tufts Medical Center, Inc. | Endovascular cerebrospinal fluid shunt |
EP3099367A4 (en) * | 2014-01-31 | 2017-10-04 | The Regents of the University of Colorado, a body corporate | Ventricular catheter |
US10226193B2 (en) | 2015-03-31 | 2019-03-12 | Medtronic Ps Medical, Inc. | Wireless pressure measurement and monitoring for shunts |
US10272230B2 (en) | 2015-10-30 | 2019-04-30 | Cerevasc, Llc | Systems and methods for treating hydrocephalus |
WO2019213613A1 (en) * | 2018-05-03 | 2019-11-07 | Microvention, Inc. | Treatment for hydrocephalus |
US11013900B2 (en) | 2018-03-08 | 2021-05-25 | CereVasc, Inc. | Systems and methods for minimally invasive drug delivery to a subarachnoid space |
US20210338991A1 (en) * | 2020-04-29 | 2021-11-04 | Medtronic Xomed, Inc. | System and Method for a Covering |
US11278657B2 (en) | 2019-04-11 | 2022-03-22 | Enclear Therapies, Inc. | Methods of amelioration of cerebrospinal fluid and devices and systems therefor |
US11278708B2 (en) | 2014-01-15 | 2022-03-22 | Tufts Medical Center, Inc. | Endovascular cerebrospinal fluid shunt |
US11419921B2 (en) | 2018-07-23 | 2022-08-23 | Enclear Therapies, Inc. | Methods of treating neurological disorders |
US11752200B2 (en) | 2018-07-23 | 2023-09-12 | Enclear Therapies Inc. | Methods of treating neurological disorders |
US11951270B2 (en) | 2020-08-05 | 2024-04-09 | Cerevasc, Llc | Systems and methods for endovascularly accessing a subarachnoid space |
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Cited By (42)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008027322A1 (en) * | 2006-08-28 | 2008-03-06 | Wyeth | Implantable shunt or catheter enabling gradual delivery of therapeutic agents |
US20110060265A1 (en) * | 2006-08-28 | 2011-03-10 | Wyeth Llc | Implantable shunt or catheter enabling gradual delivery of therapeutic agents |
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